Safety and Performance of the SUTUREFIX ULTRA and SUTUREFIX CURVED Suture Anchors in Shoulder and Hip Arthroscopic Repair

NCT03691298 | Completed Results

• 1 other identifier: 17-5010-06
• Study Type: observational
• Target: 83
• Locations: 6 countries
• Sites: 9

Brief Summary

The scientific justification is to fulfill post-market clinical requirements in order to support re-certification of the CE-Mark for this marketed product and to look into safety and efficacy.

Conditions

Instability, Joint

Keywords

Suturefix; hip instability; shoulder instability

Outcome Measures

Primary Outcomes (1)

• Clinical Success at 6 Months

  Number of participants without signs of failure and/or re-intervention as assessed by the surgeon.

  6 month post-surgery

Secondary Outcomes (12)

• Clinical Success at 12 Months

  12 months post-operative

• Intra-operative Anchor Deployment Success

  Intraoperatively

• Intraoperative Suture Anchor Failure

  Intraoperatively

• Device-related Re-Intervention

  12 months

• Visual Analog Scale (VAS) Pain Score - All Participants

  6 and 12 months postoperative

Study Arms (1)

Arthroscopic hip and shoulder repair

Device: SUTUREFIX ULTRA Suture Anchor and SUTUREFIX CURVED Suture Anchor

Interventions

SUTUREFIX ULTRA Suture Anchor and SUTUREFIX CURVED Suture Anchor DEVICE

Fixation device intended to provide secure fixation of soft tissue to bone

Arthroscopic hip and shoulder repair

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subject with hip or shoulder instability

You may qualify if:

• Subject has consented to participate in the study by signing the EC-approved informed consent form
• Subject condition meets proposed indication to SUTUREFIX ULTRA and SUTUREFIX CURVED Suture Anchor
• Subject requiring shoulder or hip arthroscopic labral repair surgery from physical findings, subject symptoms and radiographic finding
• Hip subjects only:
• FAI (Femoroacetabular Impingement)
• Shoulder subjects only:
• Subject with a history of recurrent dislocation/subluxation of the shoulder

You may not qualify if:

• Participation in the treatment period of another clinical trial within thirty (30) days of Visit 1 (pre-operative)
• Women who are pregnant, nursing, or of child-bearing potential who are not utilizing highly effective birth control measures
• Contraindications or hypersensitivity to the use of the SUTUREFIX ULTRA and/or SUTUREFIX CURVED Suture Anchor, or their components (e.g. silicone, polyester). Where material sensitivity is suspected, appropriate tests should be performed and sensitivity ruled out prior to implantation
• Pathological conditions of bone, such as cystic changes or severe osteopenia, which would compromise secure anchor fixation
• Pathological conditions in the soft tissues to be attached that would impair secure fixation by suture
• Comminuted bone surface, which would compromise secure anchor fixation
• Hip subjects only:
• Dysplasia latera/central less than 20°
• Shoulder subjects only:
• Glenoid and/or humeral bone loss considered excessive by the treating orthopaedic surgeon

Sponsors & Collaborators

• Smith & Nephew Orthopaedics AG: lead

Study Sites (9)

New York University Langone Orthopaedic Center

New York, New York, 10016, United States

Location

Orthotennessee

Knoxville, Tennessee, 37922, United States

Location

CPH Privathospital

Farum, 3520, Denmark

Location

Pihlajalinna Turku Hospital

Turku, 20100, Finland

Location

Azienda Ospedaliera San Camillo Forlanini

Roma, 00152, Italy

Location

Asepeyo Hospital Sant Cugat

Sant Cugat del Vallès, Barcelona, 08174, Spain

Location

Hospital Universitario Fundación Jiménez Díaz

Madrid, 28040, Spain

Location

Queen Alexandra Hospital

Cosham, PO6 3LY, United Kingdom

Location

Fortius Clinic

London, W1H 6EQ, United Kingdom

Location

MeSH Terms

Conditions

Joint Instability

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Limitations and Caveats

COVID-19 pandemic impacted the study causing delays on obtaining outcome and safety data at follow-up visits for participants due to site closures and/or site restrictions. There was also an impact on participant retention due to the pandemic with participants being lost to follow-up and/or out of window visits leading to protocol deviations. Patient Reported Outcomes (PROs) were optional \& used according to surgeon preference leading to low response rates.

Results Point of Contact

• Title: Laura Everson
• Organization: Smith+Nephew

laura.everson@smith-nephew.com

+447718320892

Study Officials

• Laura Everson

  Smith & Nephew Ltd

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2018
• First Posted: October 1, 2018
• Study Start: November 7, 2018
• Primary Completion: May 21, 2021
• Study Completion: May 21, 2021
• Last Updated: January 6, 2025
• Results First Posted: January 6, 2025

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2); FI (1); ES (2); DK (1); IT (1); GB (2)